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Health In 2 Point 00

We have research on treatment efficacy — now let’s use it

The New York Times published a story this month about
one of the biggest medical trials ever organized by the federal
government, a study that showed that the newest, most expensive drugs
used to treat high blood pressure (a.k.a. hypertension) work no better
than inexpensive diuretics—water pills that flush excess fluid and salt
from the body. Moreover, the research revealed that the pricier drugs
increase the risk of heart failure and stroke.

The trial was
completed in 2002. Why is the story running now? Because six years
later, the findings still have had little impact on what doctors
prescribe for patients suffering from hypertension.

Allhat –which
stands for the Antihypertensive and Lipid-Lowering Treatment to Prevent
Heart Attack Trial—demonstrated that when, it comes to preventing heart
attacks, the diuretics—which have been used since the 1950s and cost
only pennies a day—is just as effective as newer calcium channel
blockers and ACE inhibitors that cost up to 20 times as much.

And
the diuretic is safer. Patients receiving Pfizer’s calcium channel
blocker (Norvasc) had a 38 percent greater chance of heart failure than
those on the diuretic. And those receiving AstraZeneca’s ACE inhibitor
were exposed to a 15 percent higher risk of strokes and a 19 percent
higher risk of heart failure.

Meanwhile, NYT reporter Andrew
Pollack noted, the diuretics cost only about $25 a year, compared with
$250 for an ACE inhibitor and $500 for a calcium channel blocker.

In
a rational world, the results “should have more than doubled” use of
the less expensive drugs, says Dr. Curt D. Furberg, a public health
sciences professor at Wake Forest University and the former head of the
Allhat steering committee.

But that didn’t happen. Instead the share of hypertension patients
receiving a diuretic rose only slightly: from 30 to 35 percent before
the results were announced, to roughly 40 percent a year later. Since
then, diuretic sales have leveled off, and the Times reports, and “use
of newer hypertension drugs has grown faster than the use of diuretics.”

Big Pharma Pushes Back

Why did the 42,000 patient, six-year, $100 million clinical trial have such a small impact? Furberg blames the drug industry.

Consider
how Pfizer reacted when Cardura, a fourth drug that went head-to-head
with diuretics in the Allhat trials, failed the test. Over the course
of the study, Furberg & Co. discovered that “patients taking
Cardura faced serious risks: they were almost twice as likely as those
receiving the diuretic to require hospitalization for heart failure.”
Alarmed that putting patients on Cardura would mean putting them in
danger, the Allhat team stopped testing Cardura in 2000, shortly before
the study formally ended.

Cardura’s manufacturer, Pfizer, was
quick to move when it heard the bad buzz surrounding its product.
“Rather than warn doctors that Cardura might not be suited for
hypertension,” says the Times¸ “Pfizer circulated a memo to its sales
representatives suggesting scripted responses they could use to
reassure doctors that Cardura was safe…” The company also mobilized its
sales staff to downplay Allhat’s findings: “[I]n an e-mail message
unearthed in…court documents, a Pfizer sales executive boasted to
colleagues that company employees had diverted some European doctors
attending an American cardiology conference from hearing a presentation
on the Allhat results and Cardura. ‘The good news,’ the message said,
‘is that they were quite brilliant in sending their key physicians to
sightsee rather than hear Curt Furberg slam Pfizer once again!’”

But Furberg did knock Cardura again in a 2004 article in
which he accused the company of treating the trial results “as a
marketing problem rather than a public health issue.” He noted that the
company never submitted the Allhat results to the FDA, nor did it make
an effort to inform doctors and patients of the risks associated with
Cardura.

Meanwhile, Pfizer touted its other entry in the
blood-pressure medication bake-off, Norvasc, the calcium channel
blocker. By 2002 Norvasc was the best-selling hypertension treatment in
the world, with sales of $3.8 billion, and Pfizer’s second-biggest drug
behind the cholesterol medication Lipitor.

The company beat the
drum for Norvasc. In a news release after the Allhat results were
announced, it claimed that Norvasc was found to be “comparable to the
diuretic in treating fatal coronary heart disease, heart attacks and
stroke.” And, the Times reports, “in a medical journal advertisement, it proclaimed ‘ALL HATs off’ to its drug.

Neither the news release nor the ad included the 38 percent greater risk of heart failure with Norvasc that Allhat exposed.

Pfizer
CEO Hank McKinnell was emphatic in his support for the drug “Contrary
to what you might have read in the press,” Mr. McKinnell said, “Allhat
is extremely positive for Norvasc. It will be our job to explain that
to the medical community.”

And Pfizer did just that. By 2006 sales had hit $4.9 billion—up from $3.8 billion in 2002. That year, Mayoclinic.com advised patients:
“A large group of medical experts known as the Joint National Committee
on Prevention, Detection, Evaluation, and Treatment of High Blood
Pressure recommends that most people should try thiazide diuretics as the first choice to treat high blood pressure and heart problems related to high blood pressure. But Big Pharma’s money talked louder.

Meanwhile,
critics emerged—as they always will—to question the design of the
Allhat trial. And a smaller, less definitive Australian study declared
an ACE inhibitor superior to a diuretic. This all muddied the waters.

But
the hundreds of millions that drug-makers spent promoting their more
expensive products made the difference. No one was making a huge profit
on diuretics, so no one was spreading money around to market them.

What the Allhat Story Means for Health Care Reform

If you are a health care reformer, you might find this story discouraging. Certainly, when the American Prospect’s Ezra Klein reported on
it, he sounded glum: “Folks looking to things like comparative
effectiveness review to save the health care system should take the
story seriously. Evidence is only effective if physicians use it. And
right now, they have no real reason to use it.

“Even in a
system this expensive,” Klein noted, “there’s no internal incentives to
aggressively cut costs. Maybe it’s time there were.”

Klein
then suggests that doctors should be paid “by capitation—if they got a
fixed amount of money per patient, and they kept whatever they didn’t
use…it’s hard to imagine that they wouldn’t’ have been more interested
in the study’s results.

It’s not clear how capitated payment
would motivate doctors to prescribe a cheaper, equally effective drug
since it’s the patient (or his insurer), not the doctor, who pays for
the more expensive drug. Though one could argue that if doctors were
paid a lump sum to keep patients well, they would avoid a riskier
product.

But on the main point, Klein is right. Data alone won’t
cut it. Someone with clout is going to have to turn comparative
effectiveness research into health care policy.

Here we come to
the good news: the U.S. is now poised to give evidence-based medicine
the institutional backing that the Allhat research lacked. That is why
the Times ran the story last week. Three years ago, there was no hope
that research like this would translate into policies that motivate
doctors to practice evidence-based medicine, and so little reason to
lament how little effect the Allhat research had. Now there is.

Legislation Already In Congress

Both
President-elect Obama’s health care plan and the proposal for reform
outlined by Senator Finance chairman Max Baucus paper call for a
public Comparative-Effectiveness Institute. Former Senate Majority
Leader Tom Daschle, who will be the next Secretary of the Dept. of
Health and Human Services, and the point man on the transition team’s
working group on healthcare, has talked about the need for such
research to set guidelines for federal medical programs.

Moreover,
last summer, Baucus and Senate Budget Committee chair Kent Conrad in
August introduced a bill (S 3408) to create a comparative effectiveness
institute, which would function as a not-for-profit private entity, not
a federal agency. This would insulate it, at least to some degree, from
Congress and the lobbyists who woo our legislators.

At the
time, Congressional Budget Office Director Peter Orszag estimated that
the U.S. could save up to $700 billion annually in health spending by
identifying treatments that do not produce the best medical outcomes.
Orszag’s support is key: since then, President-elect Obama has
appointed him director of the Office of Management and Budget (OMB).
Widely respected, Orszag is likely to become a powerful figure in the
new administration.

Baucus has explained that
the Health Care Comparative Effectiveness Research Institute would be
"responsible for setting national priorities" for head-to-head trials
and would contract with the NIH, the Agency for Healthcare Research and
Quality and private entities to provide peer-reviewed research studies
that "answer the most pressing questions about what works in health
care.”

According to the Kaiser Daily Health Policy Report, the
Institute’s budget would be small to start—just $5 million in fiscal
year 2009—but would climb quickly to $300 million in FY 2013. It would
be funded by the federal treasury, Medicare and private insurers. Both
Karen Ignagni, president of America’s Health Insurance Plans (AHIP),
and BlueCross and BlueShield Association President Scott Serota
announced support for the plan. (As well they should—the institute
could save them billions of dollars by exposing ineffective treatments.)

But
here’s the tantalizing part of the proposal. According to Kaiser “The
Institute would be governed by a public-private Board of Governors. The
21 members of the Board would include the secretary of HHS and the
directors of AHRQ and NIH. The Board’s other 18 members, to be
appointed by the Comptroller General, would include representatives
from three of the following entities: private payers; pharmaceutical,
device and technology companies; patients and health care consumers;
physicians; and agencies administering public health programs.”

As HealthBeat observed at
the time, “[There appear to be five entities and] it seems that the 18
board members will be drawn from three of them.” Who will be left out?
To HealthBeat, the answer seems obvious: pharmaceutical, device and
technology companies should not have a seat at the
table. Their financial self-interest (which would lead them to favor
the most expensive products) creates an immediate conflict of interest.
They should be consulted; but they should not have a vote.

We’ll
see what happens. No doubt, the bill will change many times as it wends
its way through Congress. But the president-elect, Orszag, Daschle and
Baucus all recognize that we must wring the waste out of our health
care system.

Research is Available

Skeptics
suggest that even if the new administration creates a Comparative
Effectiveness Institute, it will be a long time before it generates
enough research to make a difference. But this just isn’t true. The
Institute does not have to re-invent the wheel.

We already have
comparative studies like the Allhat trial plus work done by the U.S.
Agency for Healthcare Research and Quality. Many studies have been done
in Europe, where governments regularly use such research to make
coverage decisions. As the Timesreported recently, “Membership in an international group of drug and device assessment agencies has grown to 45 from 8 in 1992.”

In
addition, the Veterans’ Administration, Kaiser Permanente and the Mayo
Clinic all have electronic databases showing how patients fitting a
particular profile have reacted to various treatments. This
observational data can be very useful.

Moreover, as Osrzag’ Congressional Budget Office pointed out in December of
2007, we’ve already seen comparative effectiveness studies on a wide
range of treatments, pitting angioplasties against drug regimens for
heart patients, gauging the effectiveness of surgery for patients with
emphysema, testing statins, and weighing mammograms against the
combination therapy of mammograms and MRIs for breast cancer. Yet for
all this research, our health care system remains bloated, inefficient
and wasteful. In other words, Allhat isn’t the first time that good
research has failed to change the game.

Part of this is because
a for-profit health care industry opposes any efforts to reduce waste.
One man’s risky and over-priced treatment is another man’s income
stream. But the other problem is that our health care system doesn’t
have a mechanism to do anything with good research except to let people
talk about it informally

TCF’s Working Group on Medicare Reform

The Century Foundation’s Working Group on Medicare Reform
already has discussed how Medicare might integrate the Institute’s
comparative effectiveness research into its coverage decisions. The
Group recognizes that Medicare would be reluctant to simply refuse to
cover a popular, widely used treatment—even if there were evidence that
it was riskier as well as more expensive than an equally effective
alternative. Politically, that is probably a non-starter.

Nor is
it likely that Medicare will refuse to cover treatments on cost alone.
This would mean putting a price on what a year of life is worth when
deciding whether to cover a drug that would give a cancer patient an
extra year. The TCF Working Group recognizes that most Americans are
not ready to see decisions made on “cost-effectiveness” alone.

But there is plenty of long-hanging fruit in the form of treatments that are less effective—and riskier—than less expensive alternatives. As we’ve discussed in an earlier post,
too often we often use advanced medical technologies on a broad swath
of patients when only a few, who fit a very specific profile, actually
benefit from it.

The TCF Working Group believes that next year,
Congress may well authorize Medicare to negotiate for discounts on
drugs for Medicare patients, and if so, it seems certain that Medicare
would take comparative risk and effectiveness into account when
deciding how much it is willing to pay.

President-elect Obama
made it clear that he believes that “drug negotiation is the right
thing to do and the smart thing to do” in 2007, when the Senate failed
to pass the Medicare Prescription Drug Price Negotiation Act. At the
time, Obama observed that
the Senate had failed “ to consider a bill that would have placed the
needs of seniors ahead of the profits of the health industry…Over the
last decade the cost of drugs has quintupled, now totaling almost $200
billion. In 2005, the drug companies’ profit was 16 percent of their
revenues, compared to only 6 percent for all Fortune 500 firms…

“The
growth in the cost of drugs has slowed in recent years, in part because
of greater use of generic drugs. But given the price tag, and the
financial challenges of our health care system, we can—and must—take
additional steps to curb how much we are spending on drugs.

“When
you look at the prices the Federal Government has negotiated for our
veterans and military men and women, it is clear that the government
can—and should—use its leverage to lower prices for our seniors as
well.” In 2009, as Medicare searches for ways to cut costs, a new
president may well find the votes to pass the legislation.

Meanwhile,
virtually everyone agrees that Medicare needs to adjust the fees that
it pays doctors, raising reimbursements for primary care doctors,
geriatricians, palliative care physicians and others who practice
“cognitive medicine”—listening to and talking to patients. In a
recession, Medicare will have to do this in what the Medicare Payment
Advisory Commission (MedPac) calls a “budget-neutral way.” In other
words, while hiking fees for doctors at the bottom of the income
ladder, Medicare should trim fees for certain very expensive services
when they are used too broadly, exposing patients to risk with little,
if any, benefit.

Today, the fees Medicare pays physicians are
determined by how much the service costs the physician in terms of
time, mental effort judgment, technical skill, physical effort and
stress. But nowhere does “benefit to the patient” figure into the
equation. If Medicare took comparative effectiveness findings into
account, private insurers, who already follow Medicare’s fee schedule,
would be almost certain to follow suit.

Finally, as Medicare
looks at the research, the Working Group believes that it would make
sense to raise co-pays for tests and treatments that offer little
benefit to certain patients. For example, as noted in a recent
HealthBeat post,
when it comes the mammograms, medical evidence has convinced the
American College of Physicians that the dangers of unnecessary biopsies
far outweighs the likelihood of saving a life for average risk women
over the age of 74. (Similarly, the U.S. Preventive Services Task Force
does not recommend mammography screening for women over 69). Older
Medicare patients who still wanted the mammograms could have them, but
they would have to pay more out-of-pocket. More importantly, news
stories explaining why patients over 74 are being asked to pay more
might well alert patients to the risks.

Why a Comparative Effectiveness Institute Would Make a Difference

Just
how much difference will an “Institute” make? Again, the Allhat story
is informative. The Allhat research disappeared because the U.S. has no
institution that advertises comparative-effectiveness research and
integrates it into the decision-making process.

As the Times
notes, in order to try to spread the word about Allhat findings, “the
federal Heart, Lung and Blood Institute had to recruit Allhat
investigators, provide them with training and then sent them to
proselytize fellow physicians. In all, 147 investigators gave nearly
1,700 talks and reached more than 18,000 doctors and other health care
providers.”

In other words, the Allhat team had to convince
doctors around the nation, one by one, that the results of its study
should change the way that they prescribe blood pressure medication.
Unfortunately, this effort was “a coffee-and-doughnuts operation
compared with the sumptuous dinners that pharmaceutical companies used
to market to doctors.” And it took the organizers a full three years to
get the outreach up and running.

This is a profoundly
inefficient way to try to promote change. You first need to transform a
clinical trial into an advocacy operation, secure funding for outreach,
coordinate nationwide networks of doctors, schedule countless meetings,
and then work to win over doctors,. Worst of all, by the time such an
endeavor gets off the ground, it may already be too late.

By
the time your physician missionaries are equipped to spread the word,
medicine may have already moved on. Earlier this year, for example, theEconomist pointed out
that one “comparative trial in the early 1990s laboriously compared
balloon angioplasty and bypass surgery over the course of many years;
but the widespread adoption of innovative heart stents in the meantime
made the results of the study almost meaningless.” When it comes to
assessing the effectiveness of a treatment, time is of the
essence—because the health care industry will always try to keep one
step ahead of objective evidence.

But what if we had a Federal
Comparative-Effectiveness Research Institute? Its recommendations
could make headlines—especially if it was influencing Medicare fees and
co-pays. This would be bound to have an impact on how both patients
and physicians perceive treatments. No physician has the time to keep
up with, review and compare all of the research in his specialty. An
unbiased Institute with a good website would serve as a clearing-house
for information.

But that is why stories like the one that the Times just
ran on Allhat are important. Today the mainstream press is making the
public more and more aware that many health care treatments are not
only over-priced but hazardous to our health. And an informed public is
becoming wary.

Americans may love new medical technologies—but
they do not enjoy being gouged, and they do not like being turned into
unwitting guinea pigs. They understand that overpriced treatments are
driving insurance premiums skyward. Articles like the Allhat story, theBusiness Weekcover story, “Do Cholesterol Drugs Do Any Good," or this piece in the New York Times–warning that angioplasty is not effective unless performed within three days after a heart attack—are drawing attention.

Indeed,
some physicians are seeing the change in their practice. A couple of
months ago, when Maggie saw a new primary care physician, she noted
that her cholesterol is a little high and suggested Maggie start taking
Lipitor, a cholesterol-lowering “stain”.

When Maggie began to
explain her objections, the doctor pursed her lips and shook her head.
“You know, these days I have a lot of patients like you say they won’t
take statins.”

Maggie started to reply, ready to give the doctor a 20-minutes riff on ‘the cholesterol con’: “That’s because the research shows that for someone who hasn’t had a heart attack …”

But
the physician cut her off. “I am not interested in continuing my
medical education,” she said crisply. Great. Medical science stopped
evolving the day she graduated. Clearly, a bad patient/doctor match.
(Maggie’s new PCP suggested that she eat fewer eggs.)

But, given
the medical evidence, the fact so many patients are questioning
statins is a good sign. Lobbyists beware. Word is getting out.

Niko Karvounis tracks the health care system for the Century
Foundation. Maggie Mahar is an award winning journalist and author. A
frequent
contributor to THCB, she is the author the
increasingly influential HealthBeat blog, one of our favorite health care reads and where this piece first appeared.

I was promoting an ARB when ALLHAT came out initially in 2002. I noticed Pfizer reps were promoting the ALLHAT trial in some way, as they had this trial in their possession at all times. Now I know why. A trial came out recently which I think was called the ACCOMPLISH trial, that showed a combo drug of a CCB with an ACE was better than a diuretic and an ACE inhibitor combo drug. However, this trial was sponsored by Novartis, who remarkably markets Lotrel, which is Norvasc and Lotensin, an ACE inhibitor. What a concidence: Cardiovascular disease, I surmise,… Read more »

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10 years ago

Guest

J Bean

Not withstanding the opinions Mr. Pollack expressed in his poorly written and misleading newspaper story, hypertension is one of those areas where the research is broadly known. The recent heaving and sighing over the 2002 ALLHAT study is a pretty good example of the difficulty of analyzing study results. The ALLHAT trial is an outlier among trials which otherwise lean slightly in the direction of the ACE-I for HTN treatment. How does a clinical physician evaluate RCTs? I’m a community doc, not an academic. I have neither the tools nor the time to ponder the significance of each individual study… Read more »

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10 years ago

Guest

MG

Unless this has real financial teeth that impacts patients and providers, it will largely be for not. Additionally, the key details are what types of evidence are used to make and judge effectiveness. After having experience doing meta-analysis, it is a messy and difficult affair. Here are just a couple of questions that come to mind: 1. Do you use studies/results based on upon solely upon observational data? If so, what are the specific criteria? 2. Do you include results from studies in other countries including Europe, Japan, and others? You could easily add another dozen or so questions to… Read more »

Deron S. and Bev MD– Thanks muh for your comments. (I’ll come back and reply to the rest of the comments tomorrow. ) Deron S, Thanks for the kind words. And I agree that the comparative effectiveness info needz to be readily accessible in EMR system so that physicians can access it on the spot. (I beleive this happens at the VA, which has made good use of its database to see what works and what doesn’t for patients who fit a particular profile. I’m pretty sure it happens at Mayo and probably Kaiser.) I also agree that, Yes, financial… Read more »

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10 years ago

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Pam K.

I agree with both Deron and Bev but for different reasons. I believe that for CE to succeed means getting all of the principle contributors to understand how a clinical trial is conducted and most importantly, why. In situations where gross assumptions have been made that each “player” around the table at a CE meeting knows what the other’s job is has led to policy and business decisions being made that are costly for the product, the prescriber and the patient. It seems like a small thing but it is highly powerful – get people communicating in the same language.… Read more »

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10 years ago

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Dan

The Gold Standard For The Management of Your Heart Cardiovascular disease, I surmise, is very concerning to both patients and their care givers. Furthermore, this disease is likely a cause of distress as well as confusion for many who seek the best treatment, once the disease presents itself. As a result, there are increasingly many pharmacological options available to delay if not prevent such diseases, yet many health care providers were understandably unclear as to which choice is the most effective with these deadly disease states manifested by substandard cardiovascular function. Hypertension, or high blood pressure, affects possibly over 70… Read more »

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10 years ago

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bev M.D.

I agree with Deron; let the scientists from Pharma sit at the table, not the salesmen. One forgets there ARE scientists at these companies, who know what they are doing. The post also raises an important point about any future comparative effectiveness institute – in addition to performing its own research, it could spend huge amounts of useful time collating and evaluating the many comparative effectiveness studies (such as the one exemplified) already out there. And BTW, I laughed out loud about Maggie and her PCP regarding statins! (The doc wasn’t saying she didn’t want to continue her education; she… Read more »

I like the concept of an unbiased institute with a good website, but it probably needs to go beyond that. The information needs to be better distributed to the clinical decision making points in the system. It needs to be integrated into EMR systems so that a physician can efficiently access it during the flow of a busy patient schedule. Unfortunately, I’m not sure this initiative alone will cut out a majority of the waste. I don’t think it can effectively address overtreatment caused by defensive medicine and financial incentives to order tests. Other steps must also be taken in… Read more »

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